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One of the primary hurdles in HCAF development is the inevitable increase in solution viscosity as mAb concentration rises. This viscosity increase poses challenges during filtration, filling, and other manufacturing processes. Additionally, highly concentrated mAb solutions may encounter solubility limitations, leading to gelation or phase separation, especially under refrigerated conditions. Such occurrences not only jeopardize formulation stability but also threaten therapeutic efficacy.
The formulation process itself creates complex challenges, particularly in unit operations like ultrafiltration-diafiltration, sterile filtration, and fill-finish steps. These challenges can impede manufacturing efficiency and escalate costs, requiring innovative solutions to streamline processes without compromising product quality.
High viscosity and mAb aggregation not only hinder manufacturing processes but also compromise syringeability and injectability during patient delivery. These issues reduce patient compliance and treatment effectiveness, highlighting the importance of formulations optimized for easy administration.
Protein aggregation poses a significant risk during manufacturing and administration which can lead to diminished therapeutic potency. Additionally, aggregate formation increases the risk of triggering anti-drug immune responses, emphasizing the need to maintain long-term storage stability while preserving formulation integrity.
Excipients play a pivotal role in mitigating viscosity, enhancing solubility, and ensuring stability in HCAF formulations. However, selecting the right excipients while maintaining formulation stability remains an art blended with science.
Pfanstiehl’s Technical Sales Scientists can discuss with you to understand your challenges and provide guidance based on experience and literature reviews to reduce the viscosity and stabilize the structure and biologic activity of your protein therapeutic.
Let us help put together some ideas for:
Incorporating stabilizing agents like sugars or polyols can protect proteins from denaturation and aggregation during storage and handling.
Pfanstiehl HPLE-LMTM Sucrose
Pfanstiehl HPLE-LMTM Trehalose
Pfanstiehl HPLE-LMTM Maltose
Pfanstiehl HPLE-LMTM Mannitol
Incorporating viscosity-reducing excipients like arginine, sodium chloride, or specific amino acids can mitigate viscosity increases while maintaining stability.
Pfanstiehl HPLE-LMTM L-Arginine
Pfanstiehl HPLE-LMTM L-Arginine HCL
Pfanstiehl HPLE-LMTM L-Histidine
Pfanstiehl HPLE-LMTM L-Histidine HCL
Adjusting the buffer system’s pH and composition can enhance solubility and stability, crucial for high concentration formulations.
Pfanstiehl HPLE-LMTM TRIS Base
Pfanstiehl HPLE-LMTM Tris HCL
Pfanstiehl HPLE-LMTM Sodium Succinate
For over 100 years, Pfanstiehl has made cGMP Injectable grade excipients, stabilizers, and buffer components that are guaranteed high purity and low endotoxin. Our components are used in the majority of the world’s top selling biopharmaceuticals and we continue to grow every year.
Our customers know that the combination of Pfanstiehl’s award winning technical support and high purity low endotoxin cGMP components will help ensure better consistency from batch to batch and reduce the risk of manufacturing batch failure for your therapeutic.
If you have a protein biologic or vaccine that requires a High Concentration Antibody Formulation (HCAF), please contact us and we will be happy to discuss how we can work together to make your product as high quality as possible.